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Acceptance Testing
New York and many other states require that new imaging equipment
be tested before first use on patients. This is also recommended
in the ACR Standard of Practice and in their Accreditation programs.
UMP has extensive experience providing acceptance testing for new
imaging equipment, including radiographic and fluoroscopic X-ray,
C-arms, CT units, Nuclear Medicine cameras, PET and PET/CT units,
MR units, mammography equipment, CR readers and PACS workstations.
Through our thorough testing and measurements, we have been able
to help clients verify that their equipment meets manufacturer specifications
and regulatory requirements, as well as identify any problem areas
that will need to be addressed to ensure that their substantial
investment in new equipment is maximized.
Most of our clients have felt that the cost of acceptance testing
by an independent, experienced physics group is extremely worthwhile
when compared with the overall cost of the new imaging equipment.
They are especially grateful on those occasions when we have discovered
significant problems that require correction before patient imaging
begins (and before full payment is made).
We believe acceptance testing by an independent physics group such
as ours is akin to having your car or house inspected by an independent
party prior to purchase. It’s a relatively small investment
for a fairly complex piece of imaging equipment. In past acceptance
testing for other clients, we have identified issues that had required
corrective action by the vendor. We have built excellent collaborative
relationships with local service engineers, because we work together
to ensure your imaging equipment works at its optimum performance.
Q&A
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Are there any requirements for acceptance testing?
Some states, like New York, require acceptance testing of all medical
diagnostic equipment before first use on patients. “Diagnostic
equipment,” includes Nuclear Imaging Systems (SPECT and PET),
CR readers and plates, and PACS workstation displays. This clarifies
the common misconception that acceptance testing is only required
for x-ray producing equipment.
Click
Here for the link to the NYS regulation
for Acceptance Testing.
Can acceptance testing be done by the manufacturer?
In New York State, the Medical Physics Licensure Law (Article 166
of the Education Law) specifies that acceptance testing is one of
the practices that may only be performed by a licensed medical physicist.
In section 8702, under the “definition of the practice of
medical physics” that “Acceptance testing” is
listed within the scope of practice.
Note that the education law is not typically enforced by NYSDOH
inspectors. The Medical Physics licensure law does not restrict
unlicensed persons from acquiring data, but rather requires oversight
from a licensed medical physicist.
The bottom line is that, in New York State, Part 16 (Health Law)
says that all diagnostic imaging equipment
must be acceptance tested, and Article 166
(Education Law) specifies that acceptance
testing must be performed by a licensed
medical physicist.
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ACR and IAC Accreditation
Assistance
Each year, more imaging departments at hospitals and private centers
are seeking to join others who have achieved accreditation by the
American College of Radiology and/or IAC (ICANL, ICACTL, etc.) in
various imaging modalities. UMP has developed substantial expertise
assisting clients through the accreditation process by providing
physics support for mammography, CT, MR, and Nuclear Medicine programs.
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Consulting –
Regulatory, Quality Control, Technology
Medical imaging is becoming anything but simpler. Not
only is the technology becoming increasingly complex,
there are a multitude of regulatory requirements and
quality control tests that change continually. We pride
ourselves in providing prompt, professional advice on
regulatory, quality, and technology issues for all our
clients. Your answer is just a short phone call or email
away. When necessary, UMP consults with a network of
colleagues in the regulatory, manufacturing, and physics
communities.
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Procedures &
Manuals
Most regulators and accreditation organizations (such
as JCAHO) require imaging departments to have current
written procedures that document routine department
activities. Written procedures also help to ensure all
affected employees are aware of expected practices.
UMP has written concise, straight-forward procedures
and manuals for numerous clients, and can tailor documents
to fit most any format.
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Magnetic Resonance
(MR)
UMP has been performing MR Medical Physics
Surveys for about 10 years when we purchased
our first ACR MR Accreditation Program (MRAP)
phantom. Though not required by NYSDOH (since
no ionizing radiation is used), our clients
have asked us to perform this service in
increasing numbers over the past few years.
In 2005, the ACR MRAP has required that
copies of the annual medical physics survey
be submitted with accreditation materials
for each scanner. Until 2005, the ACR would
accept MRAP applications without this documentation,
but no longer according to Theresa Branham,
MRAP Manager at ACR.
The ACR MRAP Site Instructions recommend
that facilities utilize their medical physicist
to assist with the phantom imaging (acquisition
and quantitative analysis) before these
images are submitted to ACR. We have performed
this service for many clients over the years,
and have assisted with accreditation of
more than a dozen MR scanners in 2007.
Since the ACR issued their newest White
Paper on MR Safety in June 2007, UMP has
provided many facilities (and their architects
and planners) with guidance in design of
new MR scanning suites and recommendations
for safety improvement for existing suites.
UMP is ready to help you to assure image
quality, safety and assist with MR Accreditation.
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